MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR, GLUCOSE, INVASIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Scarring (2061); Reaction (2414)

Event Date 12/10/2020

Event Type  Injury  

Event Description

Since around (b)(6) 2020, every dexcom sensor i have applied has caused a severe rash where the adhesive touches my skin. Every single time. These rashes take weeks to heal, and if i use any other adhesive over the place the rash was before the rash is completely gone, the rash reappears and scars. I have marks on my skin today ((b)(6) 2021) from a sensor that i removed on (b)(6) 2020. I have photos of some of these rashes that i would be happy to share. Since these rashes began, i have not been able to use the decom g6 cgm that i have come to rely on to help me care for my diabetes. My average blood sugar is decidedly worse because of this issue. Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11337543
• MDR Text Key: 232378266
• Report Number: MW5099420
• Device Sequence Number: 1
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 02/16/2021 Patient Sequence Number: 1